For clinical trials
Clinical Trial Operations
Operational support for wearable sensors and digital assessments, from study setup through data delivery.
BioSensics supports the use of wearable sensors and digital assessments in clinical studies, from study setup through data delivery. A dedicated clinical operations manager coordinates the agreed technology scope with pharmaceutical sponsors, CROs, and sites, connecting clinic and home data collection with practical support throughout the study.
Experience supporting pharmaceutical trials worldwide
BioSensics has provided study operations services to over 30 pharmaceutical companies and supported trials in over 25 countries.
One coordinated plan for your digital assessments
Align technology, people, and data around the study protocol. BioSensics works with your team to define assessment workflows, site readiness, participant support, data review, and delivery requirements before launch. Clear responsibilities and escalation pathways help teams address issues throughout the study.
What your team receives
Deliverables are agreed with your team and tailored to the selected technology, protocol, and operating plan.
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Study operations plan
A documented plan for configuration, device needs, locations, responsibilities, support arrangements, and deployment timelines.
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Training and study materials
Site manuals, participant instructions, and training materials for the configured assessments and collection workflows.
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Monitoring and issue summaries
Updates on data collection, assessment completion, technical issues, and follow-up within the agreed monitoring scope.
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Documented data deliveries
Study-specific transfer specifications, agreed data exports and reports, and documentation that supports review and interpretation.
Support across the study lifecycle
Configure the selected technology, prepare study teams, and support consistent data collection across the locations and settings in your protocol.
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Study configuration and validation
Translate protocol requirements into assessment schedules, device settings, and collection workflows. Configure and validate study-specific software and document the setup before deployment.
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Device logistics and deployment
Coordinate device preparation, provisioning, delivery tracking, replacements, and returns. Plan deployment around site readiness, enrollment timelines, and applicable country requirements.
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Site training and participant guidance
Train study teams on the selected devices and assessment workflows. Provide study-specific manuals and participant instructions, with language needs and training arrangements defined during planning.
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Data quality and completion monitoring
Review incoming data, sensor wear, assessment completion, battery status, and uploads through BioDigit Cloud. Identify gaps and technical issues for follow-up through the agreed monitoring and escalation plan.
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Technical support and coordination
Help sites and participants resolve device, software, and data-transfer issues. The clinical operations manager coordinates communication with sponsor and CRO teams, with support languages, coverage, and escalation arrangements agreed for the study.
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Data management and delivery
Define transfer specifications, formats, and delivery schedules with the study team. Prepare agreed data exports, monitoring summaries, and analysis reports with supporting documentation for review.
Connect the clinic, home, and study team
Match collection and support to the assessment setting, participant needs, and protocol schedule.
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At the study site
Use BioDigit Clinic to organize motor, speech, cognitive, and video assessments within the study visit workflow.
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At home
Use BioDigit Home to collect wearable data, digital assessments, participant-reported outcomes, and diaries between visits.
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Across study locations
Coordinate deployment, training, and support across participating sites and countries, with local needs addressed in the operating plan.
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Across the study team
Use BioDigit Cloud to give authorized teams visibility into incoming data and collection status for coordinated review and follow-up.
From study preparation to data delivery
Agree on the operating plan, prepare teams for launch, and maintain coordinated support through study closeout.
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Define and configure
Confirm protocol requirements, participating countries, and language needs. Configure the selected assessments and agree on responsibilities, support arrangements, and data specifications.
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Prepare and launch
Complete the agreed software validation, provision devices, and train study teams. Support site readiness and initial participant setup.
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Monitor and support
Review data collection and assessment completion, address technical issues, and coordinate follow-up with authorized study teams.
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Deliver and close out
Provide scheduled data deliveries, address outstanding data questions, and coordinate device returns and final agreed reports.
Quality and oversight for clinical research
Study setup addresses technology suitability, software validation, data protection, and access controls for the configured system and collection workflows.
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Device status and intended use
PAMSys and LEGSys are FDA-listed devices. Device selection considers the intended use, study population, and applicable requirements in each participating country.
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Study-specific software validation
BioDigit platforms are configured for the protocol, with validation activities focused on the software, workflows, and data requirements used in the study.
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Ethics review and consent
Collection workflows and participant instructions are aligned with the approved protocol and applicable consent requirements. Responsibilities for ethics review and study registration are defined with the sponsor and study partners.
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Electronic records and signatures
Electronic-record controls are reviewed against applicable 21 CFR Part 11 and EU Annex 11 requirements for the configured system and study workflow.
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Data privacy and security
Data collection, access, storage, and sharing are planned around applicable privacy requirements, including HIPAA and GDPR where relevant.
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Audit trails and authorized access
Role-based permissions and audit trails support traceability and controlled access to study data.
Technology for connected study workflows
Configure wearable, clinic-based, and remote assessment tools around the protocol, with study-specific deployment and support.
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At-home wearables
At-Home Wearables
Wearable sensors for recording mobility, activity, and movement measures during daily life.
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On-site assessments
BioDigit Clinic
A configurable platform for motor, speech, cognitive, and video assessments during study visits.
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At-home assessments
BioDigit Home
Remote collection of wearable data, digital assessments, and participant-reported outcomes between study visits.
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Smartwatch data
BioDigit Watch
Smartwatch-based collection of physiological and movement data, with sensor selection and recording schedules configured for the protocol.
Planning your study operations
Key questions about technology deployment, participant support, and coordination with your study team.
What does Clinical Trial Operations cover?
The service supports the deployment and use of BioSensics wearable sensors and digital assessments. The agreed scope can include study configuration, software validation, device logistics, training, technical support, data monitoring, and data delivery. Responsibilities are defined with the sponsor, CRO, and sites for the selected technology and study requirements.
How does BioSensics work with a sponsor or CRO?
A dedicated BioSensics clinical operations manager coordinates our responsibilities within the study. The study team defines points of contact, responsibilities, communication schedules, and escalation pathways before launch, so technology support fits into the broader study operating plan.
Can BioSensics support studies across multiple countries?
BioSensics has provided services to over 30 pharmaceutical companies and supported trials in over 25 countries. Each new study is planned around the participating countries, device requirements, site workflows, language needs, and support arrangements.
How are data collection issues identified and addressed?
The operations team reviews agreed indicators such as sensor wear, assessment completion, battery status, and data uploads. Gaps and technical issues are documented and routed for follow-up according to the study's monitoring plan and assigned responsibilities.
How does Clinical Trial Operations connect with the other services?
Endpoint Development helps identify and develop candidate measures through natural history studies and BioDigit Database analyses, and Regulatory Support organizes the evidence for their proposed use. Post-Approval Evidence Generation focuses on additional evidence about outcomes during treatment with approved therapies, and Data Analysis and Scientific Reporting provides the analyses and reporting. Clinical Trial Operations supports the technology setup, collection workflows, and data delivery needed to carry out the selected assessments in these and other clinical studies.
Connect your research with the right support
Coordinate endpoint development, regulatory support, study operations, analysis, and post-approval research around your program's objectives.
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Endpoint Development
Develop candidate endpoints through natural history studies and focused BioDigit Database analyses for the indication of interest.
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Regulatory Support
Organize scientific and technical evidence to support sponsor discussions about the intended use of digital measures and endpoints.
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Data Analysis and Scientific Reporting
Turn study data into documented analyses, clear findings, and scientific reports for your program.
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Post-Approval Evidence Generation
Design and conduct post-approval studies to characterize outcomes during treatment with approved therapies.
Plan digital assessment delivery for your next study
Share your study design, locations, and assessment schedule. BioSensics can then work with your team to define the configuration, deployment, monitoring, and support your program requires.